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DURECT to Present Clinical Data at the International Liver Congress™ 2017
EASL poster will feature data from a Phase 1b study of DUR-928 in nonalcoholic steatohepatitis (NASH)

CUPERTINO, Calif., April 17, 2017 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms, announced today that it will present clinical data on DUR-928 at the International Liver Congress 2017 (the 52nd annual meeting of the European Association for the Study of the Liver (EASL)), which will be held April 19-23 in Amsterdam.    

The poster presentation will report safety, pharmacokinetics and biomarker data from both cohorts of a Phase 1b study utilizing DUR-928 in patients with nonalcoholic steatohepatitis (NASH).

Presentation details:

Title:                           

"Safety and pharmacokinetics of DUR-928 in patients with   


nonalcoholic steatohepatitis – a phase 1b study"

Author:                       

W. Kemp et al.

Poster:                        

#SAT-322                              

Day & Time:              

Saturday, April 22, 08:00-18:00 Central European Time

About the International Liver CongressTM

The International Liver Congress is the annual meeting of European Association for the Study of the Liver, and the flagship event in EASL's educational calendar.  The Congress is attended by scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology, radiology and imaging. Specialists share recent data, present studies and findings, and discuss the hottest topics on liver disease.  The 2017 Congress will take place April 19-23, 2017 at the RAI Amsterdam, Amsterdam, The Netherlands. The full EASL 2017 scientific program can be found at http://ilc-congress.eu/.

About DURECT

DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms.  DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program.  An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival.  Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis.  DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery.  Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology.  For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.  POSIMIR, DUR-928, and REMOXY ER are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat NASH, other disorders of the liver,  acute organ injury, kidney diseases or psoriasis or other inflammatory conditions, the potential use of POSIMIR and REMOXY ER to treat pain, potential regulatory approvals of POSIMIR and REMOXY ER, and potential markets for our product candidates are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that future clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the potential that FDA may not grant regulatory approval of DUR-928, POSIMIR or REMOXY ER, the risks of obtaining marketplace acceptance of DUR-928, POSIMIR or REMOXY ER, if approved, the risk of delays in the commencement, enrollment or completion of clinical trials, the risk that prior clinical trials (including prior Phase 1b trials of DUR-928) will not be confirmed in subsequent trials, the potential failure of clinical trials to meet their intended endpoints, the risk of adverse decisions by regulatory agencies or delays and additional costs due to requirements imposed by regulatory agencies, additional time and resources that may be required for development, testing and regulatory approval of DUR-928, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-K filed on March 29, 2017 under the heading "Risk Factors."

 

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SOURCE DURECT Corporation

Matt Hogan, Chief Financial Officer, DURECT, 408-777-4936; or Matthew Duffy, Managing Director, LifeSci Advisors, 212-915-0685